NABL CDSCO USP <1231> USFDA Inspected — Manesar & Bangalore

Pharmaceutical Water System Validation Testing | USP 1231 | NABL | Auriga Research

NABL-accredited analytical testing — TOC, conductivity, microbial, chemical parameters and bacterial endotoxin — for Purified Water and WFI system qualification. Data formatted for inclusion in your IQ/OQ/PQ documentation packages.

Our Scope — Analytical Testing for Water System Validation

Auriga Research provides the analytical testing component of pharmaceutical water system validation — TOC (USP <643>), conductivity (USP <645>), microbial (USP <61>/<62>), bacterial endotoxin (USP <85>) and the chemical parameter battery per USP <1231>. Reports are formatted for inclusion in your IQ, OQ and PQ documentation packages.

Validation master plan authoring, qualification protocol writing, engineering sampling-plan design and CAPA documentation sit with your QA, engineering and validation team. We supply the NABL-accredited analytical data they need to close out each qualification phase — no scope ambiguity, no hidden hand-offs.

Pharmaceutical water is the most widely used raw material in drug manufacturing — its quality directly affects product safety and regulatory compliance. Auriga Research provides NABL-accredited analytical testing for Purified Water (PW), Highly Purified Water (HPW) and Water for Injection (WFI) systems, ensuring your water meets pharmacopoeial specifications and cGMP requirements at every point of use per USP <1231>.

Across all three qualification phases — Installation Qualification (IQ) verifies system construction against design specifications, Operational Qualification (OQ) confirms system operation within defined parameters, and Performance Qualification (PQ) uses intensive sampling protocols that establish baseline water quality, system capability and alert/action limits — Auriga delivers the analytical data. We test for conductivity per USP <645>, TOC per USP <643>, pH, microbial count per USP <61>/<62>, bacterial endotoxins per USP <85>, nitrates, heavy metals and all parameters required by IP, USP, EP and WHO monographs. The PQ phase typically involves daily sampling at every use point for 4-8 weeks; we routinely run that workload with NABL-accredited turnaround.

Beyond the validation phase, we support routine monitoring programmes with scheduled sample testing, trend analysis reports for OQ and PQ documentation, alert/action limit data and out-of-specification investigation support. Test reports are formatted for direct inclusion in your qualification documentation — sample point ID, pull date/time, pharmacopoeial reference and acceptance criteria all on the face of the report. The bacterial endotoxin limit of 0.25 EU/mL for WFI is harmonised across IP, USP <85>/<1231> and EP 2.6.14 / 2.2.44, so the same specification applies regardless of which pharmacopoeia your submission cites.

Water System Validation — Analytical Testing Services

Each service mapped to its USP and EP pharmacopoeial reference so QA and engineering teams can scope at a glance.

USP <643>

TOC Testing for PW and WFI

Total organic carbon testing per USP <643> and EP 2.2.44 for Purified Water and Water for Injection systems — pharmacopoeial threshold compliance with NABL-accredited reporting.

USP <645>

Conductivity Testing

Conductivity testing per USP <645> and EP 2.2.38 — Stage 1, Stage 2 and Stage 3 evaluation for PW and WFI compliance.

USP <61>/<62>

Microbial Testing

Total aerobic microbial count, total combined yeasts and moulds, and objectionable organism testing per USP <61>/<62> and EP pharmacopoeial methods.

USP <1231>

Chemical Parameter Battery

Chemical parameter testing per USP <1231> — pH, chloride, sulphate, heavy metals, nitrate and TOC — for full water-grade compliance.

USP <85>

Endotoxin Testing for WFI

Bacterial endotoxin testing per USP <85> and EP 2.6.14 against the harmonised 0.25 EU/mL limit for WFI and injectable water systems.

Trends

Trend Analysis & Monitoring Reports

Trend analysis and water system monitoring reports formatted for inclusion in OQ and PQ documentation packages — alert and action limit data ready for QA review.

How It Works — 4 Steps to Your NABL Water Testing Report

1

Get a Quote

Share your water system type (Purified Water, WFI or RODI), validation phase (IQ, OQ or PQ) and regulatory authority. Your SPOC confirms applicable parameters and testing frequency.

2

Collect and Send Your Sample

Prepare per SPOC instructions at quote stage. Each sample is bar-coded and registered in YLIMS on receipt with full chain-of-custody.

3

Testing and QA Review

Tested under NABL-accredited conditions per the agreed pharmacopoeial battery. Results pass through formal QA review before release.

4

Receive Your NABL Report

NABL report delivered digitally within committed TAT, formatted for inclusion in your IQ/OQ/PQ documentation package and accepted for CDSCO, USFDA and regulatory submission. Track via YLIMS.

Project Timelines

Test Type Turnaround Time
Chemical Parameters (TOC, conductivity, pH, chloride, sulphate, heavy metals, nitrate) 3-5 business days
Microbiological Parameters (USP <61>/<62>) 5-7 business days
Bacterial Endotoxin Testing (USP <85>) for WFI 3-5 business days
Full Pharmacopoeial Panel (USP <1231> chemical + micro + endotoxin) 5-7 business days
PQ-Phase Analytical Workload (daily sampling for 4-8 weeks) 4-8 weeks (analytical cadence)

Who Needs Water System Validation Testing

  • ✓ Pharma manufacturers setting up new WFI or Purified Water systems requiring validation testing data
  • ✓ Existing manufacturers conducting periodic revalidation of installed PW or WFI systems
  • ✓ CDMO clients requiring water quality data as part of facility qualification and tech transfer
  • ✓ Pharma companies ahead of CDSCO or USFDA inspection requiring current water system testing data
  • ✓ Sterile and parenteral manufacturers documenting WFI quality per USP <85> for ANDA filings
  • ✓ Biotech and biologics facilities requiring HPW and WFI testing for upstream and downstream processing
  • ✓ API manufacturers using PW in synthesis steps and final crystallisation rinses
  • ✓ QA and engineering teams compiling OOS investigations and CAPA evidence for water system deviations

Why Auriga for Water System Validation Testing

TOC + Conductivity + Microbial + Endotoxin Under One NABL Report

TOC per USP <643>, conductivity per USP <645>, microbial per USP <61>/<62>, endotoxin per USP <85> and the full USP <1231> chemical panel — all from one lab on one bar-coded sample chain.

Data Formatted for IQ/OQ/PQ Packages

Test reports are formatted for direct inclusion in your qualification documentation — sample point ID, pull date/time, pharmacopoeial reference and acceptance criteria all on the face of the report.

NABL Accepted by CDSCO and USFDA

NABL ISO/IEC 17025:2017 accreditation; USFDA Inspected at Manesar and Bangalore — water testing data is accepted in CDSCO inspections, ANDA filings and USFDA dossier submissions without re-testing.

Honest Scope Disclosure

Auriga provides analytical testing; protocol authoring, sampling-plan engineering and CAPA writing sit with your QA team. No hidden hand-offs, no surprise scope gaps mid-project.

Harmonised Endotoxin 0.25 EU/mL Across IP, USP and EP

The 0.25 EU/mL WFI endotoxin limit is harmonised across IP, USP <85>/<1231> and EP 2.6.14 / 2.2.44 — same specification on a single Auriga report regardless of submission pharmacopoeia.

Rush Pulls for PQ-Phase Daily Sampling

Standard chemical 3-5 days; microbial 5-7 days. Rush pulls can be arranged for PQ-phase daily-sampling intensity so the validation clock does not wait for the lab.

5+

NABL Labs

5 Cities

Delhi · Manesar · Bahadurgarh · Baddi · Bangalore

12,000+

Clients Served

1985

Arbro Group Established

Pharmacopoeial References Cited on Auriga Water Reports

  • · USP <85> — Bacterial Endotoxins Test (0.25 EU/mL WFI limit)
  • · USP <61>/<62> — Microbiological Examination of Nonsterile Products
  • · USP <643> — Total Organic Carbon (TOC)
  • · USP <645> — Water Conductivity (Stage 1/2/3)
  • · USP <1231> — Water for Pharmaceutical Purposes
  • · EP 2.2.38 Conductivity · EP 2.2.44 TOC · EP 2.6.14 Bacterial Endotoxins
  • · IP and WHO pharmaceutical water guidelines (0.25 EU/mL WFI endotoxin limit harmonised across IP, USP and EP)

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Frequently Asked Questions — Water System Validation

What is pharmaceutical water system validation?
Pharmaceutical water system validation is the documented process of demonstrating that a water purification and distribution system consistently produces water meeting predefined quality specifications per USP <1231>. It covers Purified Water (PW), Highly Purified Water (HPW) and Water for Injection (WFI) systems. Validation involves three phases: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) with intensive sampling over defined periods to establish system capability and control limits.
What is Auriga’s exact scope on water system validation?
Auriga Research provides the ANALYTICAL TESTING component of water system validation — TOC per USP <643>, conductivity per USP <645>, microbial count per USP <61>/<62>, bacterial endotoxin per USP <85> for WFI, and the chemical parameter battery per USP <1231> (pH, chloride, sulphate, heavy metals, nitrate). Test data is formatted and packaged for inclusion in your IQ, OQ and PQ qualification documentation. Auriga does not author the validation master plan or qualification protocols, design the engineering sampling plan, or write CAPA documentation for the customer’s water system — those activities sit with your QA, engineering and validation team. We supply the NABL-accredited analytical data they need to close out each qualification phase.
What parameters are tested in pharmaceutical water quality?
Pharmaceutical water testing covers conductivity (USP <645>, EP 2.2.38), total organic carbon (USP <643>, EP 2.2.44), pH, microbial count (total aerobic microbial count per USP <61>/<62>), bacterial endotoxins (USP <85>/EP 2.6.14, for WFI), nitrates, heavy metals and total dissolved solids. WFI has stricter limits than Purified Water, with an endotoxin limit of 0.25 EU/mL — and this 0.25 EU/mL limit is harmonised across IP, USP <85>/<1231> and EP 2.6.14 / 2.2.44, so the same specification applies regardless of which pharmacopoeia the submission cites. Testing follows pharmacopoeial monographs from IP, USP, EP and WHO guidelines. Routine monitoring includes point-of-use sampling and trend analysis.
What is the difference between Purified Water and WFI?
Purified Water (PW) is produced by distillation, ion exchange, reverse osmosis or other suitable methods and meets specifications for conductivity, TOC and microbial limits per USP <1231>. Water for Injection (WFI) meets all Purified Water specifications plus an additional bacterial endotoxin limit of 0.25 EU/mL. WFI is mandatory for parenteral product manufacturing, rinsing of parenteral product contact surfaces and preparation of parenteral solutions. WFI systems require more stringent design, operation and monitoring.
What is the turnaround time for water sample testing?
Individual water sample testing at Auriga Research is completed within 3-5 business days for chemical parameters (TOC, conductivity, pH, chloride, sulphate, heavy metals, nitrate), 5-7 business days for microbiological parameters per USP <61>/<62>, and 3-5 business days for bacterial endotoxin testing per USP <85>. A complete PQ-phase analytical workload — depending on sampling frequency and parameter battery — typically spans 4-8 weeks. Rush turnaround can be arranged for time-critical sampling pulls.
How often should pharmaceutical water systems be monitored?
Routine monitoring frequency depends on the water grade and system maturity. During Phase 3 (PQ) validation, daily sampling at all use points is typical for 4-8 weeks. Post-validation routine monitoring typically involves weekly or bi-weekly sampling at rotating use points, with continuous online monitoring of conductivity and TOC at critical points handled by the customer’s engineering team. Alert and action limits derived from validation data guide the monitoring programme and trigger investigation when exceeded.

Need Analytical Testing for Your Water System Qualification?

NABL-accredited TOC, conductivity, microbial and endotoxin testing per USP <1231> for Purified Water and WFI systems. Reports formatted for inclusion in your IQ/OQ/PQ documentation packages.

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